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Biotechnology: Biological Products (No Diagnostic Substances)
Clinical TrialJun 8, 2026, 04:06 PM

Century Therapeutics CNTY-813 Preclinical Data Positive; IND on Track

AI Summary

Century Therapeutics announced positive new preclinical data for CNTY-813, its iPSC-derived islet replacement therapy for Type 1 Diabetes, at the American Diabetes Association 86th Scientific Sessions. The data showed durable glucose control for over eight months in preclinical models and confirmed the efficacy of its Allo-Evasion™ 5.0 technology in maintaining normoglycemia without immunosuppression. The company has also established its Phase 1 clinical manufacturing process and remains on track for an IND submission in 4Q 2026, with initial clinical data expected in 2H 2027.

Key Highlights

  • CNTY-813 demonstrated durable glucose control for over eight months in preclinical models.
  • Allo-Evasion™ 5.0 maintained insulin secretion and normoglycemia under allogeneic immune pressure without immunosuppression.
  • Phase 1 clinical manufacturing process for CNTY-813 has been established, showing consistent endocrine purity.
  • Investigational New Drug (IND) submission for CNTY-813 is on track for 4Q 2026.
  • Initial clinical data from the first-in-human CNTY-813 study is anticipated in 2H 2027.
  • No tumorigenesis was observed in over 140 mice with more than three months of follow-up.
  • CNTY-813 contains an optimal ratio of differentiated cell types, with beta cells comprising over 50% of total cell composition.